Solvay will also be required to conduct a 10-year observational study to evaluate the incidence of fibrosing colonopathy
in cystic fibrosis patients treated with Creon, and to evaluate the risk of transmission of selected porcine viruses in treated patients, according to the FDA approval letter.
Pancreatic enzyme supplementation in cystic fibrosis patients before and after fibrosing colonopathy.
High dose pancreatic enzyme supplements and fibrosing colonopathy in children with cystic fibrosis.
The incidence of fibrosing colonopathy, associated with high doses of pancreatic enzymes and/or the use of high strength preparations in the early 1990s (7-9), caused many centres treating CF to review the practices of their patients and collaborate to produce national guidelines (4,10,11).
Individuals with CF and their parents were advised against self-adjusting the dose in the 1990s when fibrosing colonopathy was identified by other centres.